An instrument for in vitro diagnosis provides a possibility to analyse a sample taken from a patient in order to make a diagnosis of a health condition of the patient. It is important that the results of the analysis are accurate and within the specified error margins, since an inaccurate analysis result may lead to incorrect diagnosis, which may have hazardous effects.
The Directive 98/79/EC on in vitro diagnostic medical devices was recently introduced in order to protect the health and environment of patients and third parties in connection with use of such devices. The devices falling under the In Vitro Diagnostic Directive must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients. They must achieve the analytical performances stated by the manufacturer. Thus, the European Union has established some requirements to be met by an in vitro diagnostic device in order for it to be placed on the European market.
A manufacturer needs to be able to guarantee that an analysis instrument returns results within a specified analytical performance. In fact, according to the directive, the manufacturer must have a quality assurance system continuously monitoring the occurrence of any incidents which could or has put a patient at risk. Therefore, it is important to the manufacturer that not only the analysis instrument but also any accessories used in connection with the analysis instrument meet specific performance requirements. There is therefore a need for a manufacturer to control the quality of each part in a system for performing a diagnostic analysis. Thus, the manufacturer of an analysis instrument wants to have a control of the quality of accessories to be used with the analysis instrument.
Specifically, if the analysis instrument performs an analysis comprising irradiating of a sample by transmitting electromagnetic radiation through a sample carrier holding the sample, the quality of the sample carrier may greatly affect the results of the analysis. A sample carrier of poor quality may render the analysis results incorrect. In order to know the analytical performance or accuracy of the analysis results, the manufacturer needs to know the variation in quality of the sample carriers.
Thus, it is desired for the manufacturers of analysis instruments to have an increased control of the quality of sample carriers to be used in an analysis the instrument, in order to be able to guarantee the performance of the analysis instrument.